MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-04-15 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE EH7909H manufactured by Ethicon, Inc.
[3364274]
It was reported that a patient underwent funnel breast surgery on an unknown date and suture was used as fixation for the implant. Post operatively the patient developed a massive wound infection which resulted in another surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10665159]
(b)(4). The product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. This is one of two medwatches being submitted as two devices were involved in this event. See medwatch 2210968-2013-03896. The same patient is represented in each medwatch.
Patient Sequence No: 1, Text Type: N, H10
[18682763]
(b)(4): representative samples from the same lot number as the actual device were returned for evaluation. Packaging integrity testing met the requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-03895 |
| MDR Report Key | 3058035 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-03-26 |
| Date Mfgr Received | 2013-04-22 |
| Device Manufacturer Date | 2012-11-26 |
| Date Added to Maude | 2013-04-15 |
| 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 | MS. KATHY RICE |
| Manufacturer Street | 4545 CREEK ROAD MAIL LOCATION 120 |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON. SAS AUNEAU |
| Manufacturer Street | NEUILLY SUR SEINE, FRANCE |
| Manufacturer City | AUNEAU |
| Manufacturer Country | FR |
| 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 | 2013-04-15 |
| Returned To Mfg | 2013-04-17 |
| Model Number | NA |
| Catalog Number | EH7909H |
| Lot Number | EM2CGMN0 |
| ID Number | NA |
| Device Expiration Date | 2017-12-31 |
| 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 | 1. Required No Informationntervention | 2013-04-15 |