MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2014-05-02 for SAF-GEL - WOUND DRESSING W/ ALGINATE 145730 manufactured by Convatec Inc..
[20657930]
It is reported that the pt felt pain, at ankle, for 2 hours upon applying saf-gel.
Patient Sequence No: 1, Text Type: D, B5
[20963393]
Based on the available info, this event is deemed to be a serious injury based on the pt requiring prescriptive medication as ordered by physician. No add'l pt/event details have been provided to date. Should add'l info become available, a follow-up report will be submitted. Reported to the fda on (b)(4) 2014. (b)(4). Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2014-00210 |
| MDR Report Key | 3796636 |
| Report Source | 01,04,07 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-08 |
| Date of Event | 2014-04-03 |
| Date Mfgr Received | 2014-04-08 |
| Date Added to Maude | 2014-05-08 |
| 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 | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INTERIM ASSOC. |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083779293 |
| Manufacturer G1 | ACCUPAC, INC. |
| Manufacturer Street | 1501 INDUSTRIAL BOULEVARD PO BOX 200 |
| Manufacturer City | MAINLAND PA 19451020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19451 0200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAF-GEL - WOUND DRESSING W/ ALGINATE |
| Generic Name | HYDROGEL WOUND AND BURN DRESSING |
| Product Code | NAE |
| Date Received | 2014-05-02 |
| Model Number | 145730 |
| Catalog Number | 145730 |
| Lot Number | 3402A2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-02 |