MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-10-22 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE manufactured by Ethicon, Inc..
[3087435]
It was reported that a patient underwent a mitral valve repair on (b)(6) 2012 and suture was used. It was reported that the pledget was fraying. There were no adverse patient consequences. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10233295]
(b)(4): no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[19110483]
Conclusion: the actual device involved in this event was returned for evaluation. The device was microscopically evaluated. The pledget on the undispensed suture is a soft pledget, which has a fuzzier appearance compared to hard pledgets. It may have appeared too fuzzy to the end-user, but it is consistent in appearance with a soft pledget.
Patient Sequence No: 1, Text Type: N, H10
[19475020]
Conclusion: representative samples were returned for evaluation. They were visually and examined for fraying. No anomalies observed with the pledgets. No fraying observed. Additional information: the actual device batch number associated with this event is not known. The following possible batch number was reported: sxp82, lot dp6530, mfg date: 12/01/2011, exp date: 07/31/2016. In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-06701 |
| MDR Report Key | 2799380 |
| Report Source | 05,06,07 |
| Date Received | 2012-10-22 |
| Date of Report | 2012-09-28 |
| Date of Event | 2012-09-28 |
| Date Facility Aware | 2012-09-28 |
| Date Mfgr Received | 2013-01-29 |
| Date Added to Maude | 2012-10-22 |
| 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 | 2012-10-22 |
| Returned To Mfg | 2012-11-04 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-10-22 |