MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-09-29 for PERITONEAL INTRODUCER SHEATHS 70CM 9MD170 manufactured by Integra Neuroscicencs Implants Sa.
[56543344]
Package was received intact but when it was opened, the product packaging was damaged. There was no patient involvement and no delay in surgery. Additional information received from the customer on 09aug2016: the product problem was discovered when it was delivered. The box that holds the product was bent in and damaged.
Patient Sequence No: 1, Text Type: D, B5
[62582761]
Integra completed its internal investigation 14nov2016. The investigation included: method: - review of device history records. - review of complaint management database for similar complaints. Results: the device history records of ref 9md170 lot 195056 were reviewed and did not reveal any anomaly. The batch was manufactured in april 2016 and included (b)(4) products. No similar complaint was received for a product from this batch. The review of integra complaint tracking database since 2013 for 9md170 revealed no similar complaint. (b)(4). A review of integra complaint tracking database for all other biot products since 2013 revealed two similar shipping issues. Conclusion: no product was received; the complaint is unverifiable. The most likely cause is a damage during the shipment to the hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612007-2016-00038 |
| MDR Report Key | 5988769 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-09-29 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-07-28 |
| Date Mfgr Received | 2016-11-14 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2016-09-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS F-06921 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F-06921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERITONEAL INTRODUCER SHEATHS 70CM |
| Generic Name | VALVE ACCESSORIES |
| Product Code | GYK |
| Date Received | 2016-09-29 |
| Catalog Number | 9MD170 |
| Lot Number | 0195056 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-29 |