MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-08 for INVIEW MALE EXTERNAL CATHETER 97636 manufactured by Hollister Incorporated.
[4776818]
It was reported that an external catheter, hollister (b)(4) was applied to a (b)(6) user on (b)(6) at midnight. The next morning ((b)(4) 2014) at 7am the external catheter was removed with warm water and vaseline. Following removal, 2 tears were observed on the penis which appeared to be straight 'razor blade-like' tears; no bleeding was noted. The lower tear was approximately 1" and the upper tear was approximately 1/2". The tears were treated using otc antibiotic cream and body wash. The user went to his regularly scheduled doctor appointment on (b)(4) where the doctor instructed them to continue with the otc antibiotic. The user also took his dilaudid pain medicine (previously prescribed for the treatment neurofibromatosis) to ease the pain. As of (b)(6) 2014 the user's penis was completely healed.
Patient Sequence No: 1, Text Type: D, B5
[11934400]
It was reported that the caregiver had requested a sheath for her son that was longer than the normal one she used (hollister (b)(4)). The medical supplier instead provided her with a product with extra adhesive (hollister (b)(4)). The caregiver has been given the correct sku for a longer sheath product with no extra adhesive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1480288-2014-00003 |
| MDR Report Key | 3995237 |
| Report Source | 04 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-07-09 |
| Report Date | 2014-07-10 |
| Date Reported to Mfgr | 2014-07-10 |
| Date Mfgr Received | 2014-07-10 |
| Date Added to Maude | 2014-08-11 |
| 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 | ANNE RIBA |
| Manufacturer Street | 2000 HOLLISTER DR |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476805625 |
| Manufacturer G1 | ROCHESTER MEDICAL CORPORATION |
| Manufacturer Street | ONE ROCHESTER MEDICAL DR |
| Manufacturer City | STEWARTVILLE MN 55976164 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55976 1647 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVIEW MALE EXTERNAL CATHETER |
| Generic Name | SILICONE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2014-08-08 |
| Model Number | 97636 |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DR LIBERTYVILLE IL 60083 US 60083 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2014-08-08 |