MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-27 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE manufactured by Ethicon, Inc..
[3255869]
It was reported that a patient underwent rotator cuff surgery on an unknown date and suture was used. The patient also had a pin implanted during the surgery. Approximately one week post operative, the patient developed redness, systemic welts, and angioedema. Over the course of the past year the symptoms have returned sporadically. The systemic symptoms have subsided. The incision has healed. However, at times the incision becomes red and she develops welts. She has been treated with antihistamines and steroids.
Patient Sequence No: 1, Text Type: D, B5
[10608739]
(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 four medwatches being submitted as four devices were involved in this event. See also medwatches 2210968-2013-02926, 2210968-2013-02928, and 2210968-2013-02929. The same patient is represented in each medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-02927 |
| MDR Report Key | 3023464 |
| Report Source | 05,06 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-03-05 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-03-27 |
| 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 | 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 | 2013-03-27 |
| 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 | 2013-03-27 |