MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-28 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE manufactured by Ethicon, Inc..
[3109233]
It was reported that a patient underwent a reoperation for an implantation of an automated implantable cardioverter-defibrillator on (b)(6) 2012 and suture was used. The automated implantable cardioverter-defibrillator was implanted this time from the right side of the patient. The patient developed drainage, redness, and poor wound healing at the incision site. The surgeon plans to remove the suture and replace with a different suture. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10385546]
(b)(4): no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. This is one of six medwatches being submitted. Please see medwatches 2210968-2012-08482 through 2210968-2012-08487. The same patient is represented in each medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-08486 |
| MDR Report Key | 2889103 |
| Report Source | 05,06 |
| Date Received | 2012-12-28 |
| Date of Report | 2012-12-10 |
| Date Mfgr Received | 2012-12-10 |
| Date Added to Maude | 2012-12-28 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | NI |
| Manufacturer Street | NI NI |
| Manufacturer City | NI NI |
| Manufacturer Postal Code | NI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURE, NON-ABSORBABLE |
| Product Code | GAS |
| Date Received | 2012-12-28 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| 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 | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-28 |