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 2013-04-29 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE 10X42 manufactured by Ethicon, Inc..
[11490196]
(b)(4) - the actual device batch number associated with this event is not known. The international affiliate reports the following possible batch numbers:batch eem814 mfg date: 05/01/2012; exp date: 01/31/2017. In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
[17443820]
It was reported that a pediatric patient underwent an umbilical hernia repair procedure on an unknown date and suture was used. Approximately 4 to 6 weeks post-operatively, the patient experienced spitting of the suture at the umbilicus. The patient underwent a second surgery to remove the sutures. During the procedure, granuloma formation and tissue breakdown were found. Additional information requested.
Patient Sequence No: 1, Text Type: D, B5
[17744654]
(b)(4). Conclusion: 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 two medwatches being submitted as two devices were involved in this event. See also medwatch 2210968-2013-04655. The same patient is represented in each medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-04656 |
| MDR Report Key | 3083029 |
| Report Source | 05,06,07 |
| Date Received | 2013-04-29 |
| Date of Report | 2013-04-08 |
| Date Mfgr Received | 2014-01-07 |
| Date Added to Maude | 2013-04-29 |
| 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, INC. SAN LORENZO |
| Manufacturer Street | ROAD 183, KM. 8.3 INDUSTRIAL AREA |
| Manufacturer City | HATO PR 00754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00754 |
| 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 | 2013-04-29 |
| Model Number | NA |
| Catalog Number | 10X42 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-04-29 |