MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2011-07-08 for TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE 1624W manufactured by 3m Health Care.
[16566803]
Conclusions: no eval will be performed. Device or lot code not provided to manufacturer for eval. Complaint type will be monitored.
Patient Sequence No: 1, Text Type: N, H10
[16676009]
Doctor (b)(6), allergist and customer who called, stated that a pt had breast augmentation surgery on (b)(6) 2011. Dr (b)(6) alleges that tegaderm, 3m steri-strips and mastisol liquid were applied to the surgical site and were removed on (b)(6) 2011. The customer alleges pt had a severe skin reaction which extended beyond the site of application and into the axilla. Pt was prescribed 40 mg. Of prednisone for (b)(6) and then tapered the dose over the next few days. States the area is healing and dr (b)(6) states that he had seen this same pt in 2006 when she reported to him she has sensitive to adhesives. Dr (b)(6) states that this pt has hyper-reactive skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2011-00089 |
| MDR Report Key | 2161160 |
| Report Source | 04,05 |
| Date Received | 2011-07-08 |
| Date of Report | 2011-06-10 |
| Date of Event | 2011-05-13 |
| Report Date | 2011-06-10 |
| Date Mfgr Received | 2011-06-10 |
| Date Added to Maude | 2011-07-15 |
| 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 | 0 |
| Manufacturer Contact | STACEY STRAND |
| Manufacturer Street | 3M CENTER, BLDG 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517336778 |
| Manufacturer G1 | 3M HEALTHCARE |
| Manufacturer City | ST. PAUL MN 55144100 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 1000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE |
| Generic Name | 878.4020 OCCLUSIVE WOUND DRESSING |
| Product Code | MGP |
| Date Received | 2011-07-08 |
| Model Number | NA |
| Catalog Number | 1624W |
| Lot Number | UNK |
| 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 | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-08 |