MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-16 for GYNECARE MESH UNKNOWN manufactured by Ethicon Inc..
[186514798]
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
[186514799]
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2015 and an mesh was implanted. It was reported that on (b)(6) 2017 she underwent a lap ventral hernia repair surgery. It was reported that she experienced small bowel obstruction on (b)(6) 2017. It was reported that she underwent a diagnostic laparoscopic converted to open exploratory laparoscope during which two enterotomies from the first surgery were repaired on (b)(6) 2017. It was reported that the patient experienced arrhythmia and received amiodarone bolus with infusion. It was reported that she experienced distress, hypoxia and bradycardia on (b)(6) 2017. It was reported that she underwent percutaneous tracheostomy for respiratory failure on (b)(6) 2017. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02009 |
| MDR Report Key | 9835534 |
| Report Source | OTHER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-16 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SOMERVILLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 088760151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE MESH UNKNOWN |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |