MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-05 for MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[185918152]
(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. The single complaint was reported with multiple events. There are no additional details regarding the additional patient events. It is unknown which event occurred with which suture layer. Patient event reaction regarding pds suture captured in mw 2210968-2020-00965; patient event regarding deep monocryl captured in mw 2210968-2020-00966; patient event regarding 2-0 monocryl captured; patient event regarding 3-0 monocryl captured in mw 2210968-2020-00968; patient event regarding 4-0 monocryl captured in mw 2210968-2020-00969.
Patient Sequence No: 1, Text Type: N, H10
[185918153]
It was reported by an attorney that the patient underwent right immediate breast reconstruction using a muscle and fascial sparing tram flap based on the deep inferior epigastric artery perforator, left immediate breast reconstruction using a muscle-sparing tram flap based on the deep inferior epigastric artery perforator on (b)(6) 2009 during which? The abdominal wound was then closed using 0 pds sutures in the scarpa? S, 2-0 monocryl in the deep dermis and 3-0 monocryl running cutaneous sutures. The umbilicus was then fashioned towards the midline and sutures using 4-0 monocryl deep dermal sutures. The flap was then inset using 3-0 deep dermal monocryl and 4-0 monocryl subcuticular sutures. The wound was then inset using 3-0 monocryl deep dermal sutures and 4-0 monocryl subcuticular sutures.? It was reported the patient experienced? Broken sutures, opening of the wound, abdominal wound care, vac- machine for suctioning, pain, swelling, pus, bleeding, frothy draining and fever. After the suture was removed, patient experienced permanent scars and continues to have an allergic internal reaction to the suture.? No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00967 |
| MDR Report Key | 9673934 |
| Report Source | OTHER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| 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 | 2020-02-05 |