MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-15 for ESP? M001201131 20-113 manufactured by Boston Scientific - Costa Rica (coyol).
[70063165]
Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70063166]
During preparation while the physician was putting his fingers in the esp? Gloves, a hole was noticed. A new pair of gloves was used to complete the case.
Patient Sequence No: 1, Text Type: D, B5
[73848181]
Device evaluated by mfr: received one pair of size 8 gloves with its original envelope. No visible residue was found on the gloves. A visual examination of the gloves found the left glove to be without issue. The mating right glove presented a tear at the fold located in the thumb. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is considered handling damage as the event occurred prior to patient contact. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73848182]
During preparation while the physician was putting his fingers in the esp? Gloves, a hole was noticed. A new pair of gloves was used to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-02265 |
| MDR Report Key | 6407656 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-15 |
| Date of Report | 2017-02-22 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-03-15 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESP? |
| Generic Name | GLOVE, PATIENT EXAMINATION, SPECIALTY |
| Product Code | LZC |
| Date Received | 2017-03-15 |
| Returned To Mfg | 2017-03-20 |
| Model Number | M001201131 |
| Catalog Number | 20-113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |