MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-10 for MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[185920865]
Product complaint # (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. No specific information regarding events has been provided. It is unknown which layer of tissue/ incision the patient experienced reaction. Patient event/ reaction regarding 3-0 monocryl captured in mw 2210968-2020-01059; patient event /reaction regarding 4-0 monocryl captured; patient event/ reaction regarding 5-0 monocryl captured in mw 2210968-2020-01061; patient event/ reaction regarding bilat 0 pds captured in mw 2210968-2020-01062 and mw 2210968-2020-01063 ; patient event/ reaction regarding bilat 2-0 pds captured in mw 2210968-2020-01064 and mw 2210968-2020-01065; patient event/ reaction regarding bilateral 3-0 pds captured in mw 2210968-2020-01066 and mw 2210968-2020-01067.
Patient Sequence No: 1, Text Type: N, H10
[185920866]
It was reported by an attorney that the patient revision bilateral reconstructed breast, fat grafting with harvest of the flanks, thigh and arm, fat injections into the infraclavicular hollowing, suction assisted lipectomy of the arms, suction assisted lipectomy of the thighs, revision medial fat plasty with extended incision and revision of abdominal wound x2 on (b)(6) 2012 during which? Each of those 20 cm incisions were excised, revised and closed with 3-0 monocryl deep dermal sutures and 4-0 monocryl subcuticular sutures. The wound was closed using 2-0 pds deep sutures, 3-0 monocryl for the deep dermal sutures and 5-0 monocryl subcuticular sutures. The wound was then closed with 3-0 monocryl deep dermal sutures, 3-0 monocryl subcuticular sutures. The deep tissues were closed using 0 pds interrupted sutures bilaterally, 2-0 pds deep fascial sutures bilaterally and 2-0 fascial sutures bilaterally, 3-0 subcuticular sutures.? It was reported the patient experienced an undisclosed adverse event. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01060 |
| MDR Report Key | 9688434 |
| Report Source | OTHER |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-10 |
| 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. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAN |
| Date Received | 2020-02-10 |
| 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 | 2020-02-10 |