MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2011-05-23 for DUODERM EXTRA THIN 187955 manufactured by Convatec.
[2000217]
The pt's mother, a (b)(6) y/o male was involved in an accident (unk type) and he sustained a facial fracture (extent unk), he was hospitalized on (b)(6) 2011. No add'l details are known regarding the course of therapy in the hosp nor whether or not the pt underwent surgery. A duoderm dressing was used on the face just below the eye and after 3 days in hosp, the pt was discharged. One day thereafter, what was initially described as an inflammation was noticed in the area where the dressing had been placed. Although it is not known if the inflammation extended the entire shape of the dressing, it was reported to have extended beyond the margins of the dressing (below it). On response to a request for clarifying info about the nature of the "inflammation", it is now reported to first have appeared as swelling, which then became a blister. The blister is reported to have burst and caused a dark pigmentation on the pt's face. Also, the pt is seeing a physician for this problem. The event is deemed serious as the customer claims permanent impairment of bodily structure or function (facial scarring). A causal relationship between the dressing and this event is deemed possibly related because product use is temporally associated with the skin where the problem occurred.
Patient Sequence No: 1, Text Type: D, B5
[9025391]
Reported to the fda on (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2011-00015 |
| MDR Report Key | 2108652 |
| Report Source | 04,07 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-04-25 |
| Date of Event | 2011-04-22 |
| Date Mfgr Received | 2011-04-25 |
| Date Added to Maude | 2011-06-02 |
| 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 | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM EXTRA THIN |
| Generic Name | WOULD DRESSING |
| Product Code | MGQ |
| Date Received | 2011-05-23 |
| Model Number | NA |
| Catalog Number | 187955 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-05-23 |