MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-02-15 for PREPPIES SKIN BARRIER WIPE 6560 manufactured by Covidien.
[1718115]
It was reported to covidien on (b)(4) 2011 that a customer had an adverse reaction to a skin barrier wipe. The customer states she utilizes an insulin infusion set which was placed on (b)(6) 2011 and removed on (b)(6) 2011. The customer states after she removed the infusion set from the right side of her abdominal area, she noticed it was inflamed and red. The customer states she was seen by a doctor and received an injection of penicillin on (b)(6) 2011. She was then prescribed keflex 500 mg 4/day. She also states she has been on a sulfur drug called septra since (b)(6) 2011. The customer states the redness turned into an abscess and needed to be lanced with the use of a scalpel which was performed on (b)6) 2011. The wound is being packed and the customer remains on antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[8835770]
Submit date: (b)(4) 2011. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2011-00002 |
| MDR Report Key | 2005724 |
| Report Source | 04 |
| Date Received | 2011-02-15 |
| Date of Report | 2011-02-03 |
| Date of Event | 2011-01-28 |
| Date Facility Aware | 2011-01-28 |
| Report Date | 2011-02-03 |
| Date Reported to Mfgr | 2011-02-03 |
| Date Mfgr Received | 2011-02-03 |
| Date Added to Maude | 2011-04-01 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616387 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN RD. |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPPIES SKIN BARRIER WIPE |
| Generic Name | SKIN BARRIER WIPE |
| Product Code | MGP |
| Date Received | 2011-02-15 |
| Model Number | 6560 |
| Catalog Number | 6560 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN RD. AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-15 |